The FDA has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults submitted by Bristol-Myers Squibb Company and AstraZeneca.
The complete response letter issued by the FDA follows the recommendations of the The U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee which voted against the drug, in July 2011, saying that the efficacy and safety data do not provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials.
Bristol-Myers Squibb and AstraZeneca will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.
Bristol-Myers Squibb and AstraZeneca remain committed to dapagliflozin and its development. This commitment is based on the benefit-risk profile of this investigational medicine, from a clinical development program that included more than 8,000 adult patients with type 2 diabetes (with more than 5,000 patients treated with dapagliflozin) in 19 clinical trials.